MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SURESCAN; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number 97714

Device Problems Malposition of Device (2616); Human-Device Interface Problem (2949); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190); Patient Device Interaction Problem (4001)

Patient Problems Complaint, Ill-Defined (2331); Device Embedded In Tissue or Plaque (3165)

Event Date 03/27/2014

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 39286-65, serial#: (b)(4), implanted: (b)(6) 2014, product type: lead.Product id: 97792, serial#: (b)(4), implanted: (b)(6) 2014, product type: accessory.Product id: 39286-65, serial/lot #: (b)(4), ubd: 17-dec-2017, udi#: (b)(4).Product id: 97792, serial/lot #: (b)(4), ubd: 17-dec-2017.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a manufacturer representative (rep) and the patient regarding the patient's implantable neurostimulator (ins) for post lumbar laminectomy syndrome and spinal pain.Information was reported that the patient stated that his ins was removed because the patient had a problem with the ins, but the lead and anchor are still implanted.The patient stated he wants to know the locations so he can have an mri done.The patient reported that the ins was initially implanted on the wrong side, and four months after the implant, the healthcare provider (hcp) performed a revision surgery on the patient.The patient stated that during the revision surgery, she was "flopping around on the table", and that loosened the patient up.The patient reported he had a bad l4 and l5, and felt good for 3.5 months.The patient stated he was also told he healed very well, but got the ins removed.It was understood that the event date was the date of implant.The rep stated that they attempted to take the lead out, but they couldn't get it out.They cut the wires so that the lead is completely inactive, but still remains in the body.No further complications were reported.No additional patient symptoms were reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the rep.It was reported that no manufacturer representative was present at the time of the implant.Rep called the patient multiple times regarding the lead return status.Patient had no interest in talkingto the rep.The clinic won¿t give rep any info.He isn¿t a manufacturer company's patient as far as they are concerned.No further complications were reported.

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 9565148
• MDR Text Key: 175016087
• Report Number: 3004209178-2020-00484
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169109483
• UDI-Public: 00643169109483
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2015
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/08/2020
• Date Device Manufactured: 03/03/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR